BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    125° RADIOLUCENT TARGETING ARM

    MDR report key: 19398026 · Received May 24, 2024

    Report

    Report Number
    1220246-2024-03923
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    February 27, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028652
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1267-100 RADIOLUCENT TARGETING ARM LOT NUMBER: 210923 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED WEAR AND TEAR AND THE DEVICE WAS SLIGHTLY DISCOLORED WHERE THE NAIL ATTACHES. THE MOST LIKELY CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED USE. FUNCTIONAL TESTING WAS PERFORMED BY ASSEMBLING THE 1267-100 RADIOLUCENT TARGETING ARM WITH AN 0617-300 LAG SCREW SHEATH LOT NUMBER: P12888 AND IT WAS FOUND THAT THE 1267-100 RADIOLUCENT TARGETING ARM WOULD NOT HOLD THE LAG SCREW SHEATH TIGHTLY AND SECURELY IN THE INSERTION HOLE AS INTENDED. IT WAS NOT NOTED THAT THE BUTTON WAS STICKING. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED USE. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 4/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1267-100 RADIOLUCENT TARGETING ARM WAS UNABLE TO KEEP THE LAG SCREW SHEATH TIGHT INSIDE THE JIG INSERTION HOLE. IT WAS STATED THAT THE JIG BUTTONS WERE "STICKING" AND NOT HOLDING THE OUTER SHEATH AS IT WAS PRIOR. THE CASE WAS COMPLETED WITH ALL STANDARD INSTRUMENTATION. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND NO DELAY IN THE CASE. THIS WAS DISCOVERED DURING A TROCHANTERIC NAIL FOR INTERTROCH FX PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305850 125° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM 210923 00848665028652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown